NCT00235339

Brief Summary

The purpose of this study is to investigate the effect of the standard rehabilitation offered by three hospital rehabilitation units in Norway, one in Trondheim, one in Ålesund and one in Levanger, compared to an interval treadmill training program. The subjects participating in the study are patients with myocardial infarction. The maximal oxygen consumption of the subjects will be tested before and after the training period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 14, 2012

Status Verified

May 1, 2012

Enrollment Period

2.3 years

First QC Date

October 7, 2005

Last Update Submit

May 11, 2012

Conditions

Myocardial Infarction

Keywords

Oxygen ConsumptionExerciseRehabilitation

Outcome Measures

Primary Outcomes (1)

  • change in maximal oxygen consumption

    At baseline, following intervention and at 6 months after the intervention. An additional follow-up test will be conducted in all patients who want to participate during 2009.

    baseline, after intervention and at 6 months

Secondary Outcomes (4)

  • quality of life

    baseline, after intervention and at 6 months

  • flow mediated dilatation

    baseline, after intervention and at 6 months

  • echocardiography

    baseline, after intervention and at 6 months

  • blood markers

    baseline, after intervention and at 6 months

Study Arms (2)

1

ACTIVE COMPARATOR

Standard exercise training rehabilitation at the hospital

Behavioral: Exercise training

2

EXPERIMENTAL

Interval exercise training on treadmills, with high intensity

Behavioral: Exercise training

Interventions

Exercise trainingBEHAVIORAL

Standard exercise training at the hospital, two times per week for twelve weeks

1

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Myocardial infarction 2-12 weeks ago

You may not qualify if:

  • Heart failure
  • limitations to walking on a treadmill
  • failure to reach a maximal pre-test(\> NYHA class II)
  • uncontrolled hypertension
  • COPD
  • pregnancy
  • kidney failure (creatinin \> 140)
  • drug abuse
  • left ventricle EF \< 30%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sykehuset Levanger

Levanger, Levanger, 7600, Norway

Location

Ålesund Hospital

Ålesund, 6026, Norway

Location

St.Olav Hospital

Trondheim, 7006, Norway

Location

Related Publications (2)

  • Moholdt T, Aamot IL, Granoien I, Gjerde L, Myklebust G, Walderhaug L, Hole T, Graven T, Stolen T, Molmen-Hansen HE, Stoylen A, Skogvoll E, Slordahl SA, Wisloff U. Long-term follow-up after cardiac rehabilitation: a randomized study of usual care exercise training versus aerobic interval training after myocardial infarction. Int J Cardiol. 2011 Nov 3;152(3):388-90. doi: 10.1016/j.ijcard.2011.08.025. Epub 2011 Sep 9. No abstract available.

    PMID: 21907424RESULT

  • Moholdt T, Aamot IL, Granoien I, Gjerde L, Myklebust G, Walderhaug L, Brattbakk L, Hole T, Graven T, Stolen TO, Amundsen BH, Molmen-Hansen HE, Stoylen A, Wisloff U, Slordahl SA. Aerobic interval training increases peak oxygen uptake more than usual care exercise training in myocardial infarction patients: a randomized controlled study. Clin Rehabil. 2012 Jan;26(1):33-44. doi: 10.1177/0269215511405229. Epub 2011 Sep 21.

    PMID: 21937520RESULT

MeSH Terms

Conditions

Myocardial InfarctionMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Stig A Slørdahl, Dr.med

    National Taiwan Normal University

    STUDY CHAIR

  • Trine T Moholdt, Cand.polit

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 10, 2005

Study Start

October 1, 2005

Primary Completion

February 1, 2008

Study Completion

December 1, 2009

Last Updated

May 14, 2012

Record last verified: 2012-05

Locations

NO(3)